Leica Biosystems PELORIS_PELORIS II - Manual (Page 13)

Leica PELORIS™ User Manual Rev K © Leica Biosystems Melbourne Pty Ltd 2011 13
Regulatory Approvals
FCC Compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1.
This device may not cause harmful interference
2. This device must accept any interference received, including interference that may cause undesired operation.
FCC Class B compliance statement
This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:

Reorient or relocate the receiving antenna

Increase the separation between the equipment and receiver

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected

Consult the dealer or an experienced radio or television technician for help.
CE Marking and European Union Notice
The CE mark on the equipment indicates compliance with the EEC Directives for Electromagnetic
Compatibility (89/336/EEC), Waste Electrical and Electronic Equipment (02/96/EC), Restriction on the Use
of Certain Hazardous Substances in Electrical and Electronic Equipment (02/95/EC), and In Vitro Diagnostic
Medical Devices (98/79/EC). Marking of equipment in this manner denotes that the equipment meets the
technical standards detailed above.
Declaration of Conformity
A “Declaration of Conformity” in accordance with the preceding directives and standards has been made, and is on file at
Leica Biosystems Newcastle Ltd, Balliol Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United Kingdom.
Note: To maintain compliance with the above CE and FCC Rules and Regulations, use only the cables supplied with the
equipment.
IEC 61010-1 
2nd Edition
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1
General requirements
UL 61010A-1 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1
General requirements
CAN/CSA C22.2
No.1010-1 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1
General requirements
IEC 61010-2-010 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2
Particular requirements for the heating of materials
IEC 61010-2-081 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2
Particular requirements for automatic and semi-automatic laboratory equipment for analysis and
other purposes
IEC 61326 Electrical equipment for measurement, control and laboratory use – EMC requirements
FCC Part 15 Class A/B Unintentional Radiators
ISO 13485: 2003 Medical Devices – Quality management systems – Requirements for regulatory compliance